Comparing different radiation therapies for nasopharyngeal carcinoma

Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC

This study is testing whether a new combination of proton and carbon ion radiation therapy is just as effective and safe as a different combination of photon and carbon ion radiation therapy for people newly diagnosed with nasopharyngeal carcinoma.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Proton and Heavy Ion Center (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06846450 on ClinicalTrials.gov

What this trial studies

This phase 3 non-inferiority trial aims to compare the efficacy and toxicity of proton radiation therapy combined with carbon ion radiation therapy against photon radiation therapy combined with carbon ion radiation therapy for patients with newly diagnosed nasopharyngeal carcinoma. Participants will be randomly assigned to receive either treatment approach, and the study will evaluate progression-free survival as the primary outcome, along with secondary outcomes including overall survival and patient-reported outcomes. The trial utilizes a web-based randomization system to ensure balanced allocation based on disease stage and response to prior chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with pathologically confirmed nasopharyngeal carcinoma and no distant metastasis.

Not a fit: Patients with distant metastasis or those who have had previous radiotherapy to the head and neck region will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and less toxic treatment option for patients with nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with proton and carbon ion therapies, but this specific comparison is novel.

Eligibility criteria

Inclusion criteria:

* Willingness to sign the written informed consent.
* Pathologically confirmed Nasopharyngeal carcinoma.
* Patients with any stage of disease except distant metastasis.
* Age: ≥ 18 and ≤ 70 years old.
* Eastern Cooperative Oncology Group score: 0-1.
* Adequate laboratory test results.
* Willingness to accept adequate contraception.

Exclusion criteria:

* Presence of distant metastasis.
* Previous radiotherapy to head and neck region.
* Previous surgery (except for biopsy) for the primary lesion or cervical lymph nodes.
* History of malignant tumor within the past 5 years.
* Presence of multiple primary tumors.
* Presence of diseases that may interfere with the evaluation of study endpoints.
* Presence of severe major organ dysfunction.
* Mental illness that may affect the understanding of informed consent.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Proton and Heavy Ion Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lin Kong

Conditions Nasopharyngeal Cancinoma; Proton; Photon; Carbon ion; Phase 3 Trial; Locally Advanced NPC